Expiratory Muscle Training for Persons With Neurodegenerative Disease

CompletedPhase 2Phase 3Relapsing MSNCT00856518

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Maximum Expiratory Pressure (MEP) 0.00042
Maximum Expiratory Pressure (MEP) 0.0019
Swallow-related Quality of Life (SWAL-QOL) 0.004
Swallow-related Quality of Life (SWAL-QOL) 0.007
Swallow-related Quality of Life (SWAL-QOL) 0.014
Swallow-related Quality of Life (SWAL-QOL) 0.016
Swallow-related Quality of Life (SWAL-QOL) 0.016
Swallow-related Quality of Life (SWAL-QOL) 0.022
Swallow-related Quality of Life (SWAL-QOL) 0.027
Swallow-related Quality of Life (SWAL-QOL) 0.031
Swallow-related Quality of Life (SWAL-QOL) 0.036
Swallow-related Quality of Life (SWAL-QOL) 0.038
Swallow-related Quality of Life (SWAL-QOL) >0.05
Swallow-related Quality of Life (SWAL-QOL) > 0.05
Swallow-related Quality of Life (SWAL-QOL) > 0.05
Maximum Expiratory Pressure (MEP) 0.899
Maximum Expiratory Pressure (MEP) 0.946

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • EMST

Placebo

  • Sham

Results by group

Maximum Expiratory Pressure (MEP)

at baseline and again after 5-week EMST exercise

GroupValueIntervalNumber analysed
Arm 1: EMST78.6 cm H2O30.72 (Standard Deviation)20
Arm 2: Sham75.56 cm H2O27.68 (Standard Deviation)16
Arm 1: EMST99.00 cm H2O32.97 (Standard Deviation)20
Arm 2: Sham99.38 cm H2O37.59 (Standard Deviation)16

Arm 1: EMST

78.6

Arm 2: Sham

75.56

Arm 1: EMST

99

Arm 2: Sham

99.38

p = 0.899

Penetration-Aspiration Scale Score

at baseline and again after 5-week EMST exercise

GroupValueIntervalNumber analysed
Arm 1: EMST40.0 percentage of group participants20
Arm 2: Sham14.3 percentage of group participants14
Arm 1: EMST45.0 percentage of group participants20
Arm 2: Sham64.3 percentage of group participants14
Arm 1: EMST15.0 percentage of group participants20
Arm 2: Sham21.4 percentage of group participants14

Swallow-related Quality of Life (SWAL-QOL)

at baseline and after 5-week of EMST exercise

GroupValueIntervalNumber analysed
Arm 1: EMST83.3 percentage of possible perfect score11.5 (Standard Deviation)19
Arm 2: Sham Group81.4 percentage of possible perfect score10.9 (Standard Deviation)13
Arm 1: EMST88.1 percentage of possible perfect score10.8 (Standard Deviation)19
Arm 2: Sham Group84.4 percentage of possible perfect score8.5 (Standard Deviation)13
Arm 1: EMST90.0 percentage of possible perfect score20 (Standard Deviation)19
Arm 2: Sham Group80.8 percentage of possible perfect score25 (Standard Deviation)13
Arm 1: EMST97.4 percentage of possible perfect score7.3 (Standard Deviation)19
Arm 2: Sham Group86.2 percentage of possible perfect score18.9 (Standard Deviation)13
Arm 1: EMST73.5 percentage of possible perfect score16.9 (Standard Deviation)19
Arm 2: Sham Group75.4 percentage of possible perfect score13 (Standard Deviation)13
Arm 1: EMST82.4 percentage of possible perfect score16.6 (Standard Deviation)19
Arm 2: Sham Group77.6 percentage of possible perfect score11.6 (Standard Deviation)13
Arm 1: EMST84.2 percentage of possible perfect score16.2 (Standard Deviation)19
Arm 2: Sham Group83.1 percentage of possible perfect score13.5 (Standard Deviation)13
Arm 1: EMST92.3 percentage of possible perfect score9.5 (Standard Deviation)19
Arm 2: Sham Group83.6 percentage of possible perfect score15.8 (Standard Deviation)13
Arm 1: EMST95.3 percentage of possible perfect score7 (Standard Deviation)19
Arm 2: Sham Group91.2 percentage of possible perfect score13.1 (Standard Deviation)13
Arm 1: EMST96.9 percentage of possible perfect score4.5 (Standard Deviation)19
Arm 2: Sham Group91.2 percentage of possible perfect score9.8 (Standard Deviation)13
Arm 1: EMST80.5 percentage of possible perfect score22.2 (Standard Deviation)19
Arm 2: Sham Group79.2 percentage of possible perfect score14.8 (Standard Deviation)13
Arm 1: EMST89.2 percentage of possible perfect score20.4 (Standard Deviation)19
Arm 2: Sham Group84.6 percentage of possible perfect score11.3 (Standard Deviation)13
Arm 1: EMST87.2 percentage of possible perfect score21.5 (Standard Deviation)19
Arm 2: Sham Group83.4 percentage of possible perfect score16.5 (Standard Deviation)13
Arm 1: EMST94.1 percentage of possible perfect score18.2 (Standard Deviation)19
Arm 2: Sham Group90.2 percentage of possible perfect score13 (Standard Deviation)13

p = > 0.05

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Arm 1: EMST240 (0.0%)
Arm 2: Sham Group180 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Maximum Expiratory Pressure (MEP)

    at baseline and again after 5-week EMST exercise

    Nerve conduction tests
  • Penetration-Aspiration Scale Score

    at baseline and again after 5-week EMST exercise

    Safety
  • Swallow-related Quality of Life (SWAL-QOL)

    at baseline and after 5-week of EMST exercise

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 35 to 80

Show the full criteria

Inclusion criteria

* Multiple Sclerosis Participants * Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist * Over 85% of the patient populations that come from the study sites demonstrate relapsing-remitting MS with an average relapse frequency of once every 3 years Parkinson's Disease Participants * Hoehn \& Yahr, stage II and III as indicated by certified movement disorders neurologist All Participants * Between 35 and 80 years of age * Non-smoking or no smoking within the previous five years * No history of head and neck cancer, asthma or COPD, untreated hypertension * Sufficient facial muscle strength so as to achieve and maintain adequate lip closure around a circular mouthpiece * Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE; 1975No neurological (other than MS or PD) condition which adversely affects respiratory muscle or gas exchange system * Reduced MEP's compared to published normative data for age and sex * Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s for 65 and older) during voluntary cough production for age and sex (Bolser, personal communication; Smith-Hammond \& Goldstein, 2006) * Participant report of symptoms related to swallow impairment

Exclusion criteria

* DBS * COPD * Asthma * Smoking or smoking within preceding 5 years

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Respiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become sedentary and lose endurance, maximal fitness levels and overall pulmonary function. Much of the research focus has been on the motor symptoms of PD and MS yet the pulmonary and swallowing complications are perhaps ultimately the most important disability as the diseases progress. The inability to generate adequate respiratory pressure is responsible for reduced cough magnitudes and cough response times. Cough is critical for the clearance of foreign materials in the airway helping to reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough function an increased risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are a number of promising outcomes from an expiratory strength-training program. By increasing expiratory muscle strength and expiratory pressure generation, effective breathing, clearance of the airway, and improved swallowing can occur. These explicit outcomes are predicted based on our experience with the use of an innovative device-driven, home-based expiratory strength training program focused on the expiratory muscles of respiration. This project focuses on following patients with PD and MS for an initial 5 weeks of strength training and them testing the outcome of a caregiver program for maintaining treatment effects.

Papers

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    History

      1. Started

        Mar 2009

      2. Main results due

        Aug 2014

      3. Finished

        Aug 2014

      4. Results posted

        Nov 2016

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